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Prediction of Clinical Irrelevance of PK Differences in Atorvastatin Using PK/PD Models Derived From Literature-Based Meta-Analyses

To support the development of a fixed-dose combination (FDC) of ezetimibe and atorvastatin for the treatment of dyslipidemia, bioequivalence (BE) studies were conducted across a combined dose range (10/10, 10/20, 10/40, and 10/80 mg of ezetimibe/atorvastatin). In the BE trials, all parameters met tr...

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Detalles Bibliográficos
Autores principales: Vargo, R, Adewale, A, Behm, M O, Mandema, J, Kerbusch, T
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4062834/
https://www.ncbi.nlm.nih.gov/pubmed/24682029
http://dx.doi.org/10.1038/clpt.2014.66